Medmarc Blog (blog.medmarc.com)
Evolving Labels and Warnings for AI-Enabled Devices: Managing Risks
When FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) and, shortly after, joined Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in...
FDA Guidance on AI Medical Devices: Predetermined Change Control Plans
One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...
Impact of Federal Funding Freeze on Clinical Trials and Patient Safety
In January 2025, the Trump administration implemented a temporary freeze on federal financial assistance programs, including grants and loans, to review their alignment with the administration’s...
A Guide to FDA's Labeling Guidelines on Biosimilars and the Implications for Products Liability
The field of biopharmaceuticals has witnessed significant advancements in recent years, particularly in the realm of biosimilars. Biosimilars are biological products that are similar to an...
FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Since the publication of the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan in 2021, interested parties have been awaiting guidance from...
The Modernization of Cosmetics Regulation Act of 2022
Cosmetic companies did not expect to be impacted so heavily by the 4155-page, 1.7 trillion-dollar omnibus spending bill enacted by Congress for this year. Within this bill is the Modernization...
FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter...